BEUDAMED
    FDA Recall Terminated

    BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.

    Recall: Z-2034-2008 · Initiated June 30, 2008

    Recall

    Recall Number
    Z-2034-2008
    Event Number
    49501
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    3004785967
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 30, 2008
    Posted
    September 26, 2008
    Terminated
    December 4, 2008
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.

    Reason

    Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)

    Action

    Medtronic Navigation notified service engineers to retest units for compliance.

    Distribution

    CA, DC, LA, FL. IN, OH, PA, VA

    Quantity

    10 units